Impact on quality of life of keratoconus patients treated with accelerated "epi-on" corneal collagen crosslinking technique: results from the NEI VFQ-25 Questionnaire in a Romanian population.

Objective: The main objective of this study was to describe vision-related quality of life (VRQoL) in a Romanian population of patients with keratoconus who underwent the accelerated "epi-on" corneal collagen crosslinking procedure and to evaluate the association with demographic data of age, gender and civil status (married, cohabitants or non-cohabitants). Method: The National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) was administered to 72 patients with keratoconus who had undergone a minimally invasive procedure. Descriptive statistics and bivariate analysis were used to determine the distribution of demographic parameters and a possible association between this parameter and the scores obtained on the NEI VFQ-25 questionnaire. Results: Based on the answers to the questionnaire we calculated the mean (SD) VFQ-25 total score, which was 73,97 (15,11), whilst scores for the subscales varied from 49.93 to 84,23. No significant difference was observed between the demographic parameters and the NEI VFQ-25 items, except for one item (being with others) when comparing paired and non-paired participants. Conclusion: In a Romanian population with keratoconus being treated with accelerated "epi-on" corneal collagen crosslinking procedure, VRQoL was reported at a high baseline level. The value of this information is significant when discussing patients' expectations during treatment. The VRQoL was not affected by age or civil status.

Vision-related quality of life among released from treatment cases of leprosy evaluated with NEI-VFQ-25: a cross-sectional study.

BACKGROUND: People with leprosy who have been declared Release From Treatment (RFT) are often not aware of the leprosy sequelae possibility which can decrease their quality of life. This could be because they have been adapting for a long time hence they do not feel the need to see physicians. This study seeks to compare the results of Vision-Related Quality of Life (VR-QoL) among RFT persons based on the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) and WHO grading disability based on physical examination. METHODS: A cross-sectional study of 325 RFT subjects from leprosy communities (Singkawang, West Kalimantan and Tangerang, Banten) was conducted between 2018 and 2019. We used the NEI-VFQ-25 questionnaire that had been validated and translated into Indonesian and distributed to the leprosy population. Relationships and comparisons among variables were evaluated using Kruskal-Wallis and Mann-Whitney tests. RESULTS: There were three main results: The median composite score of VR-QoL for WHO grade 0, 1, and 2 disabilities has decreased by 13%, 25.5%, and 30% of the maximum value, respectively. Of the total, eleven subscales were statistically significant between WHO grading disability and VR-QoL based on the NEI-VFQ-25 (p < 0.05). The comparison between grade 0 and grade 2 disability in all subscales was statistically significant (p < 0.05). CONCLUSIONS: The grade of disability is related to their VR-QoL assessment using the NEI-VFQ-25 questionnaire. Thus, it can be used as an initial screening in primary healthcare settings to increase awareness of disability before a thorough physical examination.

Artificial intelligence at the national eye institute.

PURPOSE OF REVIEW: This review highlights the artificial intelligence, machine learning, and deep learning initiatives supported by the National Institutes of Health (NIH) and the National Eye Institute (NEI) and calls attention to activities and goals defined in the NEI Strategic Plan as well as opportunities for future activities and breakthroughs in ophthalmology. RECENT FINDINGS: Ophthalmology is at the forefront of artificial intelligence-based innovations in biomedical research that may lead to improvement in early detection and surveillance of ocular disease, prediction of progression, and improved quality of life. Technological advances have ushered in an era where unprecedented amounts of information can be linked that enable scientific discovery. However, there remains an unmet need to collect, harmonize, and share data in a machine actionable manner. Similarly, there is a need to ensure that efforts promote health and research equity by expanding diversity in the data and workforce. SUMMARY: The NIH/NEI has supported the development artificial intelligence-based innovations to advance biomedical research. The NIH/NEI has defined activities to achieve these goals in the NIH Strategic Plan for Data Science and the NEI Strategic Plan and have spearheaded initiatives to facilitate research in these areas.

The NEI VFQ-25C: Calibrating Items in the National Eye Institute Visual Function Questionnaire-25 to Enable Comparison of Outcome Measures.

Purpose: To improve the usefulness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) by enabling estimation of measures on an invariant scale and comparisons between patients and across studies. Methods: Datasets of baseline NEI VFQ-25 responses from nine studies (seven retina randomized trials, n = 2770; two low vision studies, n = 572) were combined. The method of successive dichotomizations was applied to patient ratings of the main NEI VFQ-25 and six supplemental items to estimate Rasch model parameters using the R package 'msd.' Calibrated item measures and rating category thresholds were estimated for the NEI VFQ-25, as well as for two domain-specific versions: the NEI VFQ-VF that includes only visual function items and the NEI VFQ-SE that includes only socioemotional items. Results: Calibrated item measures were estimated from study participants (n = 3342) ranging in age from 19 to 103 years, with mean (SD) age of 69.3 (11) years and a mean logMAR visual acuity of 0.30 (Snellen 20/40). Item measure estimates had high precision (standard error range, 0.026-0.085 logit), but person measure estimates had lower precision (standard error range, 0.108-0.499 logit). Items were well targeted to most persons, but not to those with higher levels of function. Conclusions: Calibrated item measures and rating category thresholds enable researchers and clinicians to estimate visual, socioemotional, and combined measures on an invariant scale using the NEI VFQ-25. Translational Relevance: Applying NEI VFQ 25C calibrated item measures (software provided) to the NEI VFQ-25, users can estimate overall, visual, and socioemotional function measures for individual patients.

Chinese Version of the Vision-Related Quality of Life (NEI-VFQ-25) among Patients with Various Ocular Disorders: A Pilot Study.

Background and Objectives: Subjective visual function is currently becoming an increasing appreciation in assessing the health-related quality of life. This study aimed to assess the vision-related quality of life (VRQOL) among patients with refractive errors, keratoconus, senile cataract, and age-related macular degeneration (AMD) using the Chinese version of the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25). Materials and Methods: The questionnaire of NEI-VFQ-25 was filled out in a clinical setting or by telephone/mail. Univariate and multivariate analyses were used to determine which factors are associated with the NEI-VFQ-25. Results: From June 2018 to January 2019, 28 patients with refractive error, 20 patients with keratoconus, 61 with senile cataracts, and 17 with AMD completed the questionnaire NEI-VFQ-25. There were significant differences in the NEI-VFQ-25 subscale of general vision (p = 0.0017), ocular pain (p = 0.0156), near activities (p = 0.0002), vision-specific social functioning (p = 0.007), vision-specific mental health (p = 0.0083), vision-specific dependency (p = 0.0049), color vision (p < 0.0001), peripheral vision (p = 0.0065), and total score (p < 0.0001) among four disease groups, respectively. The multiple linear regression revealed that the best-corrected visual acuity (BCVA) and disease group were important factors of the total NEI-VFQ-25. After adjusting for BCVA, patients with AMD had a worse total NEI-VFQ-25 score than patients with refractive error, keratoconus, or senile cataracts. Conclusions: Among the patients with four ocular disorders and a broad vision spectrum from normal, partial sight, low vision to legal blindness, the BCVA of their better eye was the most important factor in the VRQOL.

Quality of life in patients with glaucoma assessed by 39-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-39).

PURPOSE: The purpose of the study was to evaluate glaucoma patients' quality of life (QoL) as measured by National Eye Institute Visual Functioning Questionnaire (NEI VFQ-39) and to examine the influence of patient characteristics and disease stage measured by visual field loss on QoL. METHODS: A prospective survey of patients with an established diagnosis of glaucoma without concomitant eye disease was conducted. Patients completed a validated German translation of the NEI VFQ-39 questionnaire. Visual field defects were graded using simplified Hodapp's classification. VFQ-39 scores were compared between groups. RESULTS: We included 60 patients, 28 of whom were classified as early, 16 as moderate, and 16 as advanced stage glaucoma. No differences were found in sex, visual acuity of the better eye, near visual acuity, treatment type, and VFQ rating for "General health" between groups. In the advanced group, VFQ-39 (p = 0.01) and VFQ-25 (p = 0.01) composite scores were significantly lower than in the early group. In addition, distance visual acuity (worse eye) was significantly worse in the advanced than in early stage patients (p = 0.04, Table 4). Patients with advanced glaucoma had significantly lower VFQ-39 subscale scores for "General vision" (p = 0.023), "Near activities" (p = 0.02), "Distance activities" (p = 0.003), "Mental health" (p = 0.008), "Driving" (p = 0.011), and "Peripheral vision" (p = 0.017) than early glaucoma patients. Patients with moderate glaucoma had significantly lower scores for "Distance activities" (p = 0.028) than early stage glaucoma patients. VFI (better eye: r = 0.65, worse eye: r = 0.5) and MD (better eye: r = 0.6, worse eye: r = 0.49) were significantly (p < 0.001) correlated with VFQ-39. Correlations of VFQ-39 with age, VFI intereye difference, distance, or near visual acuity were not significant. CONCLUSION: Compared to patients with early glaucoma, patients with moderate stage glaucoma reported higher difficulty with distance activities (e.g. navigating an urban environment, watching television). Patients with advanced stage glaucoma reported lower VFQ-39 composite and subscale scores relevant to topics of general vision complaints, difficulties with near work and finding things, navigating urban outdoor environments, and watching television; worries and frustrations with vision difficulties; and difficulty driving and noticing objects off to the side of footpaths. Visual field indices MD and VFI were strongly correlated with QoL as assessed by VFQ-39. VA was not correlated with QoL. In patients with moderate or advanced glaucoma, QoL may be significantly impacted by glaucomatous visual field defects even when visual acuity is preserved.

Interpretation of change scores for the National Eye Institute Visual Function Questionnaire-25: the minimally important difference.

AIM: To estimate the minimally important difference (MID) in change in National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score using methods aligned with patient perception. METHODS: Retrospective analysis of prospectively collected data from adults with primary angle closure or primary angle closure glaucoma enrolled in the Effectiveness, in Angle-closure Glaucoma, of Lens Extraction study. We included data from 335 participants with patient reported visual function (VFQ-25) and health status measured by the EQ-5D-3L over 36 months. We used the recommended anchor-based methods (receiver operating characteristic (ROC), predictive modelling and mean change) to determine the MID of the VFQ-25. EQ-5D-3L anchor change was defined as none (<0.065); minimal (0.065≤EQ-5D-3L change ≤0.075 points) and greater change (>0.075 points). RESULTS: Mean baseline VFQ-25 score was 87.6 (SD 11.8). Estimated MIDs in the change in VFQ-25 scores (95% CI) were 10.5 (1.9 to 19.2); 3.9 (-2.3 to 10.1); 5.8 (1.9 to 7.2) and 8.1 (1.7 to 14.8) for the 'within-patient', 'between-patient' change, ROC and predictive modelling anchor methods respectively. Excluding estimates from the methodologically weaker 'within-patient' method, the MID of a change in VFQ-25 composite score is 5.8 (median value). CONCLUSIONS: Estimates of the MID using multiple methods assist in the interpretation of the VFQ scores. In the context of early glaucoma related visual disability, a change score of around six points on the VFQ-25 is likely to be important to patients. Further confirmatory research is required. Studies comparing changes in patient-reported outcome measure scores with a global measure of patients' perceived change are required.

Artificial vision: the effectiveness of the OrCam in patients with advanced inherited retinal dystrophies.

PURPOSE: To investigate the impact of the OrCam MyEye 2.0 (OrCam) on the quality of life and rehabilitation needs in patients with advanced retinitis pigmentosa (RP) or cone-rod dystrophies (CRD). The OrCam is a wearable low-vision aid that converts visual information to auditive feedback (e.g. text-to-speech, barcode and facial recognition). METHODS: Patients with a clinical diagnosis of RP (n = 9, 45%) or CRD (n = 11; 55%), and a best-corrected visual acuity of ≤20/400 Snellen were invited to participate in this study. Questionnaires were administered at baseline and after 5.2 (standard deviation ± 1.5) weeks, which included the Dutch version of the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ), the Participation and Activity Inventory (PAI) and the OrCam Function Questionnaire (OFQ). RESULTS: Following OrCam testing, significant improvements were observed in the 'near activities' subscale of the NEI-VFQ (p < 0.001); the 'visual functioning' subscale of the re-engineered NEI-VFQ (p = 0.001); the 'reading' rehabilitation goal of the PAI (p = 0.005) and the overall score of the OFQ (p < 0.001). The observed changes in questionnaire scores did not differ between phenotypes. Advantages and limitations of the OrCam were reported by patients. Three patients (15%) continued rehabilitation with the OrCam after completion of this study. CONCLUSIONS: The OrCam mainly improves reading domains in patients with advanced stages of RP or CRD. Further improvements in the OrCam are needed to address current limitations, which may enhance its utility for patients with RP or CRD.

The NEI Audacious Goals Initiative: Advancing the Frontier of Regenerative Medicine.

Eight years since the launch of the National Eye Institute Audacious Goals Initiative for Regenerative Medicine, real progress has been made in the effort to restore vision by replacing retinal neurons. Although challenges remain, the infrastructure, tools, and preclinical models to support clinical studies in humans are being prepared. Building on the pioneering trials that are replacing the retinal pigment epithelium, it is expected that by the end of this decade first-in-human trials for the replacement of retinal neurons will be initiated.

Cross-validation of the Tunisian version of the National Eye Institute Visual Function Questionnaire 25.

INTRODUCTION: The goal of our study was to create a cross-cultural adaptation of the questionnaire « National Eye Institute Visual Function Questionnaire ¼ (NEI-VFQ-25) for the Tunisian population (Tu-VFQ-25) and to test its psychometric properties in a group of patients with chronic uveitis. PATIENTS AND METHODS: The study consisted of two steps. The first was translation of the NEI-VFQ-25 and its cross-cultural adaptation to the Tunisian dialect (Tu-VFQ-25) according to the guidelines of Beaton et al. The second step consisted of studying the psychometric properties of the Tu-VFQ-25. Enrolled patients, diagnosed with chronic uveitis, were interviewed face-to-face by two different investigators, followed by a telephone interview by the first investigator 48hours later. Feasibility, internal consistency and reproducibility of the Tu-VFQ-25 were then tested using statistical methods. RESULTS: The mean time taken to administrate the questionnaire to each of the 45 patients was 11min 40 s (± 2min 24 s). Internal consistency was acceptable, with Cronbach's alpha coefficients above 0.7 except the "Ocular Pain" and "Driving" subscales (0.645 and 0.559 respectively). Inter-observer reliability was excellent, with intra-class correlation coefficients (ICC) ranging from 0.857 to 0.985 for all subscales. Test-retest reliability, assessed for 43 patients, was good to excellent, with ICC above 0.80 for all subscales except "General Vision," which had a value of 0.786. CONCLUSION: As with previous versions, the Tu-VFQ-25 is an easy and reliable tool for assessing vision-related quality of life of Tunisian patients with chronic uveitis.

Psychometric properties of the Croatian version of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

PURPOSE: The purpose of the study was to translate, adapt and validate the Croatian version of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in participants with visual impairment. This study also aims at evaluating the relationship between visual impairment and health-related quality of life (HRQoL). METHODS: The prospective observational study was conducted at the University Hospital Centre Zagreb, Department of Ophthalmology. The sample consisted of 175 patients with four chronic ocular diseases: cataract, glaucoma, diabetic retinopathy and age-related macular degeneration. The translation of the NEI VFQ-25 to Croatian was conducted following the standardised procedure. All participants underwent an ophthalmological examination and completed the NEI VFQ-25 and the Medical Outcomes Study Short Form-36 Questionnaire (SF-36). In order to assess the psychometric properties of the NEI VFQ-25, we calculated Cronbach's α coefficient, intraclass correlation coefficient (ICC), convergent and discriminant validity, as well as criterion and concurrent validity. RESULTS: Results show high internal consistency (Cronbach α range 0.739-0.932) and high test-retest reliability (ICC 0.876-0.975) for all subscales. None of the items had failed either convergent or discriminant validity. Moderate to high Spearman's rho coefficients of correlations were found between best corrected visual acuity and eight subscales in the NEI VFQ-25 (0.430 < ρ < 0.631). Moderate correlations were found between comparable domains in the NEI VFQ-25 and in the SF-36 questionnaire (p < 0.01). CONCLUSION: The Croatian version of the NEI VFQ-25 has very good psychometric properties and can be a useful instrument for assessing vision-related quality of life in Croatian population with chronic ophthalmic diseases.

Assessment of quality of life of the patients with diabetic retinopathy using National Eye Institute Visual Functioning Questionnaire (VFQ-25).

BACKGROUND: Diabetes affects most of the organs causing macrovascular and microvascular complications. Diabetic retinopathy (DR) results from the prolonged uncontrolled hyperglycemia which causes impairment of vision. Quality of life (QoL) of patients with DR is affected due to vision loss. National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) is the questionnaire used to study the effect of DR on QoL. OBJECTIVES: To assess the QoL of the patients with DR. MATERIALS AND METHODS: The study enrolled 149 (male-104 and female 45) patients with DR. The previous translated and validated version of NEI-VFQ-25 questionnaire was used in the study. RESULTS: Cronbach alpha for internal consistency was between 0.6 and 0.8. The male patient showed significantly higher (p<0.05) QoL scores (60.73±1.63) as compared to the female patients (53.15±2.84). Hypertensive patients showed poor QoL as compared to non-hypertensive patients. The patients with a history of diabetes for 16-30 yrs. showed better QoL as compared to other patients. CONCLUSION: DR affects the QoL of life of patients. Routine assessment of QoL using NEI-VFQ-25 questionnaire would be useful for physicians and health care team.

The impact of advanced age-related macular degeneration on the National Eye Institute's Visual Function Questionnaire-25.

PURPOSE: To assess visual function among patients diagnosed with age-related macular degeneration (AMD) by stage of disease and laterality. METHODS: This is a cross-sectional cohort study of 739 AMD patients and their responses to the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at time of study enrolment. Patients with AMD were categorized into Early/Intermediate AMD and three groups of advanced AMD: (i) neovascular AMD (NV), (ii) geographic atrophy (GA) and (iii) Both Advanced forms. These three advanced stages were further stratified into unilateral or bilateral advanced disease. Mean composite scores and subscale scores for 12 different areas were based on a 100-point scale with the lowest and highest possible scores set at 0 and 100, respectively. Scores for the advanced AMD groups were compared with Early/Intermediate AMD using general linear modelling. RESULTS: A total of 739 AMD patients (294 Early/Intermediate, 115 GA, 168 NVAMD and 162 Both Advanced) were included in the analysis. Mean composite scores were highest among Early/Intermediate patients (89.9), followed by patients diagnosed with unilateral disease in the Both Advanced (88.0) and NV (86.1) groups. Mean composite scores were similar for bilateral NV (82.9) and unilateral GA (81.7), and mean scores were lowest for the bilateral GA (71.3) and bilateral Both Advanced (68.5) groups. In general, this pattern persisted across the twelve subscales as well. Subscale scores ranged from a low of 35.1 for driving among bilateral Both Advanced patients to a high of 99.2 for colour vision among patients with unilateral Both Advanced. Overall, patients with unilateral advanced disease consistently had higher mean scores than their bilateral counterparts. The largest difference was 19.5 composite score points between the unilateral and bilateral Both Advanced groups, there was a difference of 10.4 points between the GA groups, and a relatively small difference of 3.2 points between the NV groups. CONCLUSIONS: We found large differences in visual function as reported from the VFQ-25 across the different types of advanced stage AMD groups and number of eyes affected with advanced AMD. These findings demonstrate the importance of accounting for the type and number of eyes affected by advanced stage AMD.